[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100628065":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":41,"responsibleParty":58,"collaborators":26,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":26,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":26,"overallStatus":44,"whyStopped":26,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Group A: will undergo a cryopressotherapy protocol using a dedicated device\u002Fmachine.","EXPERIMENTAL","Cryopressotherapy treatment (using the device) consists of applying the machine in 6-hour cycles per day, to be performed 3 hours in the morning and 3 hours in the afternoon during the 4 days after surgery.",[13],"Device: Cryopressotherapy",{"label":15,"type":16,"description":17,"interventionNames":18},"Group B: will undergo a cryotherapy protocol using ice.","ACTIVE_COMPARATOR","Cryotherapy (i.e., cold therapy) consists of applying local ice using an ice pack 3 times per day, with 1-hour applications alternating 15 minutes on and 15 minutes off during the first 4 days after surgery.",[19],"Device: Ice pack",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Cryopressotherapy","Comparison between Cryopressotherapy and ice pack in patients undergoing Total Knee Arthroplasty to improve clinical outcomes",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Ice pack","Comparison between ice pack and cryopressotherapy",[15],[32],{"name":33,"affiliation":34,"role":35},"Laura Mangiavini","University of Milan, IRCCS Ospedale Galeazzi-Sant'Ambrogio","PRINCIPAL_INVESTIGATOR",[37],{"name":33,"role":38,"phone":39,"phoneExt":26,"email":40},"CONTACT","0283506790","laura.mangiavini@unimi.it",[42],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":46,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"IRCCS Ospedale Galeazzi-Sant'Ambrogio, Milan, Milan 20173","RECRUITING","Milan","Italy","20157","IT",{"type":50,"coordinates":51},"Point",[52,53],12.59836,42.78235,{"lat":53,"lon":52},[56],{"name":33,"role":38,"phone":57,"phoneExt":26,"email":40},"283506790",{"type":59,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100628065","use-of-cryopressotherapy-in-patiens-undergoing-total-knee-replacement-to-improve-clinical-outcome-100628065",false,"NCT07456787","Use of Cryopressotherapy in Patiens Undergoing Total Knee Replacement to Improve Clinical Outcome","CRYO-KNEE","Inclusion Criteria:\n\n* Candidates for elective total knee arthroplasty surgery (indication determined solely by the Orthopedic Surgeon)\n* Patients aged between 18 and 80 years (inclusive) for both groups\n* Body Mass Index (BMI) between 18 and 35 kg\u002Fm²\n* Willingness and ability to provide informed consent\n* Patients with non-inflammatory degenerative knee joint disease, including osteoarthritis\n\nExclusion Criteria:\n\n* Use of medications that may interfere with muscle metabolism\n* Bone metastases or diseases at the surgical site\n* Presence or suspicion of infection at the knee\n* Inability to provide informed consent\n* Obesity (BMI ≥ 35 kg\u002Fm²)\n* Patients requiring revision surgery of total knee arthroplasty\n* Patients with pacemakers and\u002For mechanical implants or those who may be affected by BIA interference","ALL","18 Years","80 Years",{"count":71,"type":72},78,"ESTIMATED","INTERVENTIONAL",[75],"NA","The purpose of this study is to evaluate the effectiveness of cryopressotherapy in patients undergoing total knee arthroplasty by assessing clinical improvement using the KOOS at 14 days after surgery.\n\nAnalysis of the knee Range of Motion (ROM) in the preoperative phase, at the predischarge visit, and at the follow-up visit for suture removal performed 14 days after surgery.\n\nAnalysis of PROMs such as: Oxford Knee Score (OKS), Joint Forgotten (JF), NRS score, and SF-12.\n\nThese questionnaires will be collected in the preoperative phase, at the predischarge visit, and at the follow-up visit for suture removal performed 14 days after surgery.\n\nTo evaluate whether cryopressotherapy leads to an improvement in predischarge hemoglobin (Hb) levels.\n\nTo assess whether cryopressotherapy reduces the circumference and subcutaneous fluid accumulation of the operated limb.",[78,79],"Total Knee Arthroplasty\\(TKA\\)","Osteoartrosi","2026-03-03",{"date":82,"type":83},"2026-03-06","ACTUAL",{"date":85,"type":83},"2025-09-29",{"date":87,"type":72},"2028-02",{"name":5,"class":6},1]